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FDA 510(k)

SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE

K-Number: K031286 · 2003-05-29

ApplicantAesculap, Inc.
Decision Date2003-05-29
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2003-05-29 under 510(k) number K031286. 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 SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE?

SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2003-05-29. The listed applicant is Aesculap, Inc.. The 510(k) number is K031286.

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

SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE received FDA 510(k) clearance on 2003-05-29, under 510(k) number K031286.

Who is the listed applicant for SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE?

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

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

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

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Other records listing Aesculap, Inc. as applicant

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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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