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510(k) K810014

REPLACABLE BATTERY HI-TEMP CAUTERY by Medical Products Development, Inc. — Product Code HAM

K810014 is an FDA 510(k) premarket notification submitted by Medical Products Development, Inc. for the device "REPLACABLE BATTERY HI-TEMP CAUTERY". The FDA issued a decision of Substantially Equivalent on February 12, 1981. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Medical Products Development, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1981
Date Received
January 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Medical Products Development, Inc.

  • K810013 — MULTIPERFECTEMP CAUTERY (April 23, 1981)
  • K810016 — REPLACABLE BATTERY PERFECTEMP CAUTERY (April 23, 1981)
  • K810012 — MULTIMICRO SURGICAL CAUTERY (April 23, 1981)
  • K803067 — SURG-FLEX 10 LIGHT (February 26, 1981)
  • K810015 — MULTIHI-TEMP CAUTERY (February 12, 1981)
  • K802942 — HITEMP. TM 2 LOOPTIP CAUTERY (February 4, 1981)
  • K810019 — SURG-FLEX 15 SURGICAL LIGHT (January 23, 1981)
  • K810018 — SURG-FLEX 5 SURGICAL LIGHT (January 23, 1981)
  • K810017 — MICROSURG CAUTERY (January 5, 1981)
  • K802330 — HI-TEMP LOOPTIP SURGICAL CAUTERY (November 12, 1980)

Other clearances for product code HAM

  • K153472 — Quiver Laparoscopic Extendable (June 23, 2016)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K945861 — BERGEN 710 ESU (March 1, 1995)
  • K913300 — LAPAROSTAT(TM) (April 2, 1992)
  • K920100 — GSU HANDPIECE ADAPTER (February 3, 1992)
  • K911353 — EMC MODEL NO. STATOME 900 (June 24, 1991)
  • K901248 — ABC HANDPIECE ADAPTER (April 3, 1990)
  • K881334 — LIGHT COAGULATOR LC 250 (November 16, 1989)
  • K895337 — ELECTROSURGICAL COAGULATION SUCTION TUBE (September 15, 1989)

FDA data resources