Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA product code GAM · 134 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4493
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1991-03-14 – 2026-06-25

GAM 2000-08-10

POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)

Applicant Cp Medical

K number K002190

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GAM 2000-03-30

MONOFILAMENT BIOSYN SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K000037

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GAM 2000-02-09

POLYGLYCOLIC ACID

Applicant Trading Consultants and Distributors Intl., Inc.

K number K994001

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GAM 1999-09-03

BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant Genzyme Surgical Product (Genzyme Biosurgery)

K number K992088

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GAM 1999-06-22

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant Genzyme Surgical Product (Genzyme Biosurgery)

K number K991191

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GAM 1999-06-04

SURGISORB

Applicant Samyang Corp.

K number K984374

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GAM 1999-05-27

SURGISORB

Applicant Sutures , Ltd.

K number K990432

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GAM 1999-04-01

MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K990951

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GAM 1998-06-25

POLYSORB SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K981935

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GAM 1998-05-18

DEXON RAPID (DEXON R)

Applicant Davis & Geck, Inc.

K number K980610

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GAM 1998-05-11

SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant Aesculap, Inc.

K number K980704

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GAM 1998-02-13

PANACRYL

Applicant ETHICON, Inc.

K number K974299

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GAM 1997-08-14

DEXON VIOLET

Applicant Davis & Geck, Inc.

K number K972566

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GAM 1997-05-13

MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS

Applicant Medline Industries, Inc.

K number K971208

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GAM 1997-05-05

MODIFIED USSC* POLYSORB SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K970863

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GAM 1997-04-25

MODIFIED E-PACK PROCEDURE KIT

Applicant ETHICON, Inc.

K number K970317

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GAM 1997-02-12

LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.

Applicant Lukens Medical Corp.

K number K965162

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GAM 1996-12-16

ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED

Applicant ETHICON, Inc.

K number K964345

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GAM 1996-10-08

SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K963253

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GAM 1996-08-02

COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED

Applicant ETHICON, Inc.

K number K962480

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GAM 1996-07-16

USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K961997

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GAM 1995-10-18

POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K953869

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GAM 1995-08-21

USSC POLYSORB SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K951520

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GAM 1995-08-21

USSC MONOFILAMENT POLYSORB SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K945285

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GAM 1995-06-15

VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT

Applicant ETHICON, Inc.

K number K946271

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GAM 1995-06-05

DEXON S, DEXON PLUS, AND DEXON II POLYGLYCOLIC ACID SUTURE

Applicant Davis & Geck, Inc.

K number K951352

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GAM 1995-05-19

SYNTHETIC ABSORBABLE SUTURE

Applicant Johnson & Johnson International

K number K944937

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GAM 1995-01-18

VICRYL RAPIDE SUTURE

Applicant ETHICON, Inc.

K number K944110

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GAM 1994-01-07

ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE

Applicant ETHICON, Inc.

K number K930772

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GAM 1994-01-07

DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID

Applicant Davis & Geck, Inc.

K number K930588

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GAM 1993-12-17

SUTURES

Applicant ETHICON, Inc.

K number K930360

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GAM 1993-11-17

SYNTHETIC ABSORBABLE SURGICAL SUTURE

Applicant United States Surgical, A Division of Tyco Healthc

K number K930746

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GAM 1992-03-23

COATED VICRYL* II

Applicant ETHICON, Inc.

K number K915835

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GAM 1991-03-14

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE

Applicant Pfizer Hospital Products Group, Inc.

K number K905482

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