SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM— 510(k) K962789

Name: FDA 510(k) clearance K962789
Creator: U.S. Food and Drug Administration
Published: 1996-08-14

Substantially Equivalent

Smith & Nephew Endoscopy, Inc.

FDA 510(k) clearance K962789 for SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM, Substantially Equivalent on 1996-08-14. Applicant: Smith & Nephew Endoscopy, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew Endoscopy, Inc.
Product code: Code GEY
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1996-07-17
Decision date: 1996-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS2002-03-28
K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS)2001-11-14
K972308 — MEDNEXT 1000 DRILL1997-08-20
K971941 — AQUA SPRAY1997-08-14

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K093428 — SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR2009-12-17
K083226 — SMITH & NEPHEW PEEK INTERFERENCE SCREW2009-01-30
K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW2009-01-30

Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.