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510(k) K802865

SAFE T COUNT by Instranetics, Inc. — Product Code KDC

K802865 is an FDA 510(k) premarket notification submitted by Instranetics, Inc. for the device "SAFE T COUNT". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code KDC (Instrument, Surgical, Disposable), a Class I device regulated under 21 CFR 878.4800. Instranetics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
November 12, 1980
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 Instranetics, Inc.

  • K823430 — INSTRA-SAFE (January 7, 1983)
  • K811823 — SHARPS CADDY FB (July 20, 1981)
  • K811824 — CAUTERY CADDY PAD (July 20, 1981)
  • K811822 — TIP-VU (July 20, 1981)
  • K810294 — LINE CADDY (February 26, 1981)
  • K810208 — BLADE SAFE (February 12, 1981)
  • K802866 — SHARPS CADDY MAGNETIC & SHARPS CADDY FOA (November 17, 1980)
  • K781575 — DISPOSABLE LYMPHANGIOGRAM SET (December 4, 1978)
  • K770894 — NEURO-SORB PATTIES (June 20, 1977)

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)
  • K912834 — SHUR-GRIP (July 26, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K905240 — VESSELOOPS (February 6, 1991)
  • K903649 — BRADLEY TENACULUM HOLDER (November 2, 1990)

FDA data resources