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FDA 510(k)

BIOMER * PLEDGET SUTURE BUTTRESS

K-Number: K832138 · 1984-05-23

ApplicantETHICON, Inc.
Decision Date1984-05-23
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIOMER * PLEDGET SUTURE BUTTRESS is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K832138. The device is classified under product code KGS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMER * PLEDGET SUTURE BUTTRESS?

BIOMER * PLEDGET SUTURE BUTTRESS is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is ETHICON, Inc.. The 510(k) number is K832138.

When did BIOMER * PLEDGET SUTURE BUTTRESS receive FDA 510(k) clearance?

BIOMER * PLEDGET SUTURE BUTTRESS received FDA 510(k) clearance on 1984-05-23, under 510(k) number K832138.

Who is the listed applicant for BIOMER * PLEDGET SUTURE BUTTRESS?

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 BIOMER * PLEDGET SUTURE BUTTRESS?

The FDA product code for BIOMER * PLEDGET SUTURE BUTTRESS is KGS.

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Other records listing ETHICON, Inc. as applicant

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Related Devices (Code: KGS)

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.

K030031SOFT TISSUE ANCHORING WASHERSAccu-Speed, IncorporatedK020480RBMSmith & Nephew, Inc.K964935SUTURE LOCKSmith & Nephew Endoscopy, Inc.K941740ACUFEX ROTATOR CUFF FIXATION BUTTONAcufex Microsurgical, Inc.K930675MITEK CONE WASHERMitek Surgical Products, Inc.K904435VENTROFIL TENSION RELIEF SUTURE SETAesculap, Inc.

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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