Home / 510(k) Clearances / K841325

510(k) K841325

REPLACE-A-TIP RECHARG. LOW TEMP. by Suncoast Medical Manufacturers, Inc. — Product Code HQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
April 2, 1984
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 Suncoast Medical Manufacturers, Inc.

  • K841604 — ADJUST-A-TEMP HIGH TEMPERATURE (December 7, 1984)
  • K841603 — ADJUST-A-TEMP MICRO (December 7, 1984)
  • K841459 — REPLACE-A-TIP ADJUST. LOW TEMP.- (December 7, 1984)
  • K841509 — REPLACE-A-TIP ADJUSTABLE HIGH TEMP. (December 7, 1984)
  • K841591 — PYRO-TIP (October 31, 1984)
  • K840376 — SURG-A STAT LOOP TIP (October 26, 1984)
  • K840375 — SURG-A-STAT LOOP TIP 15 (July 23, 1984)
  • K840377 — SURG-A-STAT CARDIOVASCULAR TIP (July 23, 1984)
  • K840387 — SURG-A-STAT LOOP TIP 2 (July 23, 1984)
  • K840370 — SURG-A-STAT VASECTOMY TIP (July 23, 1984)

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)