VASECTOMY DRAPE— 510(k) K921657

Substantially Equivalent

Graham Medical Products

FDA 510(k) clearance K921657 for VASECTOMY DRAPE, Substantially Equivalent on 1993-03-18. Applicant: Graham Medical Products. Device class: 2.

Clearance details

Applicant: Graham Medical Products
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1992-04-07
Decision date: 1993-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holyoke, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Graham Medical Products

K922100 — DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE1993-03-15
K922059 — DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #5991993-03-03
K913447 — DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #5991992-02-07
K913448 — DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE1992-02-07
K913560 — STOPCOCK1991-12-31

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