Home / 510(k) Clearances / K912834

510(k) K912834

SHUR-GRIP by Inman Medical Corp. — Product Code KDC

K912834 is an FDA 510(k) premarket notification submitted by Inman Medical Corp. for the device "SHUR-GRIP". The FDA issued a decision of Substantially Equivalent on July 26, 1991. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Inman Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1991
Date Received
June 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Inman Medical Corp.

  • K933171 — INMAN IRRIGATION TAPERED PROBE (April 29, 1994)
  • K933169 — INMAN ENDOSCOPIC BLUNT DISSECTOR (April 19, 1994)
  • K933094 — INSUFFLATOR TUBING KIT W/FILTER (April 18, 1994)
  • K933382 — IMC CABLE/WIRE COVER (January 27, 1994)
  • K933774 — IMC SALINE WET DRESSING (November 8, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (September 16, 1993)
  • K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 31, 1993)
  • K933371 — IMC ENDOSCOPIC INSTRUMENT HOLDER (August 6, 1993)

Other clearances for product code KDC

  • K943229 — DISPOSABLE SURGICAL SCISSORS AND FORCEPS (August 19, 1994)
  • K936226 — SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET (March 7, 1994)
  • K920153 — THERMUFF BAG (July 1, 1992)
  • K920263 — MANUAL SURGICAL INSTRUMENTS (May 6, 1992)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K914960 — INSTRUMENT ORGANIZER (February 28, 1992)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)

FDA data resources