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510(k) K852332

TABLE ACCESSORIES, OPERATING ROOM by Scholten Surgical Instruments, Inc. — Product Code BWN

K852332 is an FDA 510(k) premarket notification submitted by Scholten Surgical Instruments, Inc. for the device "TABLE ACCESSORIES, OPERATING ROOM". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Scholten Surgical Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
May 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Scholten Surgical Instruments, Inc.

  • K072051 — NOVATOME, MODEL: SU101-50 (October 3, 2007)
  • K900405 — SCHOLTEN FRAME (March 1, 1990)
  • K852331 — SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC (August 1, 1986)
  • K852119 — TEMPORARY PACEMAKER GROUND WIRE (September 15, 1985)
  • K852120 — FORCEPS, BIOPSY(NON RIGID) (July 2, 1985)
  • K852330 — RETRACTOR, SURGICAL (June 27, 1985)
  • K852329 — STAND, OPERATING ROOM (June 14, 1985)

Other clearances for product code BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K935441 — INFINITECH BREATH EZ (February 7, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K875291 — SPINAL SURGERY FRAME (January 22, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K860177 — ALLEN UNIVERSAL STIRRUP (February 11, 1986)

FDA data resources