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510(k) K820758

BOUNDARY SINGLE-USE CRANIOTOMY SHEET by The Buckeye Cellulose Corp. — Product Code KKX

K820758 is an FDA 510(k) premarket notification submitted by The Buckeye Cellulose Corp. for the device "BOUNDARY SINGLE-USE CRANIOTOMY SHEET". The FDA issued a decision of Substantially Equivalent on April 29, 1982. The device falls under product code KKX (Drape, Surgical, Antimicrobial), a Class II device regulated under 21 CFR 878.4370. The Buckeye Cellulose Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1982
Date Received
March 22, 1982
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 The Buckeye Cellulose Corp.

  • K822925 — BOUNDARY SINGLE-USE GOWNS (January 12, 1983)
  • K823173 — ARRIRM SCRUB BRUSH/SPONGE (November 22, 1982)
  • K821564 — BOUNDARY PROCESS CHANGE (July 2, 1982)
  • K820116 — BOUNDARY (February 23, 1982)
  • K813450 — BOUNDARY SINGLE-USE DRAPES (January 22, 1982)
  • K813390 — BONDARY SINGLE-USE OR GOWN (January 5, 1982)
  • K813277 — BOUNDARY DRAPE TAPE (December 18, 1981)
  • K813263 — PATIENT UNDERPAD (November 27, 1981)
  • K812962 — BOUNDARY SURGICAL DRAPE (November 20, 1981)
  • K812738 — BOUNDARY PROCESS CHANGE (November 16, 1981)

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)

FDA data resources