510(k) K801068

STERILE ABDOMINAL PAD by Medspec Corp. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 20, 1980
Date Received: May 6, 1980
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 Medspec Corp.

K813012 — STERILE BASIN SETS (November 6, 1981)
K812711 — STERILE GAUZE PADS 12PLY (November 2, 1981)
K812707 — STERILE DISSECTOR SPONGES-X-RAY DETECT (November 2, 1981)
K812710 — STERILE LAPAROTOMY SPONGES-X-RAY DETECT (November 2, 1981)
K812709 — STERILE DENTAL ROLL (October 23, 1981)
K810071 — STERILE SILICONE TUBING (February 12, 1981)
K810069 — STERILE AIRWAY (February 2, 1981)
K802060 — STERILE TONSIL SPONGES (October 10, 1980)
K801069 — STERILE ISOLATION GOWN (May 20, 1980)
K800278 — MEDSPEC SAFETY PINS (May 2, 1980)

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)