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510(k) K823061

BRUSH, SCRUB, OPERATING ROOM by Seamless Hospital Products Co. — Product Code GEC

K823061 is an FDA 510(k) premarket notification submitted by Seamless Hospital Products Co. for the device "BRUSH, SCRUB, OPERATING ROOM". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code GEC (Brush, Scrub, Operating-Room), a Class I device regulated under 21 CFR 878.4800. Seamless Hospital Products Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1982
Date Received
October 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Scrub, Operating-Room
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Seamless Hospital Products Co.

  • K841769 — INTERMITTENT URETHRAL CATHETER TRAY (August 24, 1984)
  • K821134 — DC PACK TM (June 22, 1982)
  • K820490 — IV START TRAY (March 16, 1982)
  • K781127 — CONNECTING TUBE, CONDUCTIVE, SURG. (September 20, 1978)

Other clearances for product code GEC

  • K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK (July 7, 1997)
  • K960621 — EXPANDACELL INSTRUMENT WIPE (April 1, 1996)
  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K896085 — SURGI-BRUSH (November 8, 1989)
  • K875033 — STERILE SCRUBBY SCRUB BRUSH (February 19, 1988)
  • K875129 — STERI-CLENS (February 18, 1988)
  • K872823 — DELTA SCRUB (January 7, 1988)
  • K874653 — STERILE SURGICAL SCRUB BRUSH (December 30, 1987)
  • K874741 — STERI-CLENS(TM) SURGICAL SCRUB SPONGE (December 10, 1987)
  • K870258 — BIOSCRUB SURGICAL SCRUB BRUSH (February 24, 1987)

FDA data resources