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FDA 510(k)

ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE

K-Number: K931271 · 1994-01-07

ApplicantETHICON, Inc.
Decision Date1994-01-07
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K931271. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE?

ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is ETHICON, Inc.. The 510(k) number is K931271.

When did ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE receive FDA 510(k) clearance?

ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE received FDA 510(k) clearance on 1994-01-07, under 510(k) number K931271.

Who is the listed applicant for ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE?

The FDA 510(k) record lists ETHICON, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE?

The FDA product code for ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE is GAQ.

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Other records listing ETHICON, Inc. 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.

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial SutureK252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesK253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceK253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical SutureK252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceK243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

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Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.K172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLCK082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated

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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