510(k) K905701

RICHARD-ALLAN SHEET CLIP by Richard-Allan Medical — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 19, 1991
Date Received: December 20, 1990
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drape, Surgical, Antimicrobial
Device Class: Class II
Regulation Number: 878.4370
Review Panel: HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

Other clearances by Richard-Allan Medical

K942207 — REFLEX INS INSUFFLATION NEEDLE (May 27, 1994)
K935105 — REFLEX ESP WITH FINGER SWITCHES (February 22, 1994)
K933508 — REFLEX SDD SURGICAL STAPLER (November 23, 1993)
K933901 — REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) (November 19, 1993)
K924881 — REFLEX(R) ESP (July 23, 1993)
K924929 — REFLEX(R) ECA (July 21, 1993)
K905682 — RICHARD-ALLAN CLAMP COVERS (February 19, 1991)

Other clearances for product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
K200238 — ControlRad Sterile Cover (April 26, 2020)
K163556 — MediClear PreOp (September 14, 2017)
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
K140195 — SURGICAL DRAPE (September 10, 2014)
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)