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510(k) K810294

LINE CADDY by Instranetics, Inc. — Product Code HXB

K810294 is an FDA 510(k) premarket notification submitted by Instranetics, Inc. for the device "LINE CADDY". The FDA issued a decision of Substantially Equivalent on February 26, 1981. The device falls under product code HXB (Probe), a Class I device regulated under 21 CFR 888.4540. Instranetics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1981
Date Received
February 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
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)
  • K810208 — BLADE SAFE (February 12, 1981)
  • K802865 — SAFE T COUNT (December 18, 1980)
  • 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 HXB

  • K960539 — DIAO HAND SURGERY SET (July 23, 1996)
  • K943472 — COHORT AVB RETRACTOR SYSTEM (October 20, 1994)
  • K912843 — FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (September 24, 1991)
  • K890227 — SURGICAL PROBE (January 27, 1989)
  • K873651 — BLUNT MEASURING PROBE W/2MM GRADATIONS #TM-1375 (November 2, 1987)
  • K873652 — HOOK PROBE #TM-1376 (November 2, 1987)
  • K863149 — BOWEN PROBE (September 5, 1986)
  • K841971 — 2.5MM & 4MM PROBE K841969-LABELING (June 19, 1984)
  • K840558 — SHUTT PRECISION PROBES (April 25, 1984)
  • K802951 — I.M PROBES (December 17, 1980)

FDA data resources