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FDA 510(k)

SYNTHETIC ABSORBABLE SURGICAL SUTURE

K-Number: K930746 · 1993-11-17

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1993-11-17
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNTHETIC ABSORBABLE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1993-11-17 under 510(k) number K930746. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHETIC ABSORBABLE SURGICAL SUTURE?

SYNTHETIC ABSORBABLE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 1993-11-17. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K930746.

When did SYNTHETIC ABSORBABLE SURGICAL SUTURE receive FDA 510(k) clearance?

SYNTHETIC ABSORBABLE SURGICAL SUTURE received FDA 510(k) clearance on 1993-11-17, under 510(k) number K930746.

Who is the listed applicant for SYNTHETIC ABSORBABLE SURGICAL SUTURE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHETIC ABSORBABLE SURGICAL SUTURE?

The FDA product code for SYNTHETIC ABSORBABLE SURGICAL SUTURE is GAM.

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Other records listing United States Surgical, A Division of Tyco Healthc as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

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Related Devices (Code: GAM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureETHICON, Inc.K253530Trexon™ Monofilament Synthetic Absorbable SutureMedtronicK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureETHICON, Inc.K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)Internacional Farmacéutica S.A DE C.V

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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