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510(k) K801078

PERFECTEMP OPHTHALMIC CAUTERY by Medical Products Development, Inc. — Product Code HQP

K801078 is an FDA 510(k) premarket notification submitted by Medical Products Development, Inc. for the device "PERFECTEMP OPHTHALMIC CAUTERY". The FDA issued a decision of Substantially Equivalent on June 4, 1980. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Medical Products Development, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1980
Date Received
May 7, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cautery, Thermal, Battery-Powered
Device Class
Class II
Regulation Number
886.4115
Review Panel
OP
Submission Type

Other clearances by Medical Products Development, Inc.

  • K810016 — REPLACABLE BATTERY PERFECTEMP CAUTERY (April 23, 1981)
  • K810013 — MULTIPERFECTEMP 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)
  • K810014 — REPLACABLE BATTERY HI-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)

Other clearances for product code HQP

  • K121441 — CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FIN (July 20, 2012)
  • K083428 — F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTER (September 1, 2009)
  • K062659 — KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES (March 9, 2007)
  • K023506 — SURGICAL MEDICAL DEVICE CAUTERY (January 13, 2004)
  • K002547 — STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (October 20, 2000)
  • K994019 — CAUTERY GRASPER/DISSECTOR (January 20, 2000)
  • K990728 — THERMAL CAUTERY DEVICE, FORCEPS (June 3, 1999)
  • K952784 — OXBORO-MEDICAL CAUTERY TIP CLEANER (July 13, 1995)
  • K945761 — LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP (April 10, 1995)
  • K945763 — LOW TEMPERATURE CAUTERY ELONGATED FINE TIP (February 7, 1995)

FDA data resources