FDA 510(k)

ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED

K-Number: K920978 · 1994-02-15

Decision Date1994-02-15

Product CodeGAN

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K920978. The device is classified under product code GAN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED?

ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is ETHICON, Inc.. The 510(k) number is K920978.

When did ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED receive FDA 510(k) clearance?

ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED received FDA 510(k) clearance on 1994-02-15, under 510(k) number K920978.

Who is the listed applicant for ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED?

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 ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED?

The FDA product code for ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED is GAN.

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Related Devices (Code: GAN)

K003015SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBDSurgical Specialties Corp K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)ETHICON, Inc.K951231ORTHOPEDIC PACKSSterile Concepts, Inc.K895579POLYSORB SYNTHETIC ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco Healthc K900198DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.American Cyanamid Co.

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.