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510(k) K875260

EFFNER CAUTERY INSTRUMENTS by Effner and Spreine Co. — Product Code HQP

K875260 is an FDA 510(k) premarket notification submitted by Effner and Spreine Co. for the device "EFFNER CAUTERY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on June 6, 1988. The device falls under product code HQP (Unit, Cautery, Thermal, Battery-Powered), a Class II device regulated under 21 CFR 886.4115. Effner and Spreine Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1988
Date Received
December 22, 1987
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 Effner and Spreine Co.

  • K874755 — EFFNER FE-EX* OROGASTRIC (April 6, 1988)
  • K872480 — KAHN-TACT U.S.A., EFF LARYNGOSCOPE (August 10, 1987)
  • K852014 — EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA (August 7, 1985)

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