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FDA 510(k)

ETHICON* SURGICAL SUTURES W/COMPRESS BOL

K-Number: K812819 · 1981-11-20

ApplicantETHICON, Inc.
Decision Date1981-11-20
Product CodeKGS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHICON* SURGICAL SUTURES W/COMPRESS BOL is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K812819. 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 ETHICON* SURGICAL SUTURES W/COMPRESS BOL?

ETHICON* SURGICAL SUTURES W/COMPRESS BOL is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is ETHICON, Inc.. The 510(k) number is K812819.

When did ETHICON* SURGICAL SUTURES W/COMPRESS BOL receive FDA 510(k) clearance?

ETHICON* SURGICAL SUTURES W/COMPRESS BOL received FDA 510(k) clearance on 1981-11-20, under 510(k) number K812819.

Who is the listed applicant for ETHICON* SURGICAL SUTURES W/COMPRESS BOL?

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 ETHICON* SURGICAL SUTURES W/COMPRESS BOL?

The FDA product code for ETHICON* SURGICAL SUTURES W/COMPRESS BOL is KGS.

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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: 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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