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FDA 510(k)

SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM

K-Number: K962789 · 1996-08-14

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date1996-08-14
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 1996-08-14 under 510(k) number K962789. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM?

SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-14. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K962789.

When did SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM receive FDA 510(k) clearance?

SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM received FDA 510(k) clearance on 1996-08-14, under 510(k) number K962789.

Who is the listed applicant for SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM?

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

What is the FDA product code for SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM?

The FDA product code for SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM is GEY.

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

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Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., 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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