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510(k) K952151

STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204) by Storz — Product Code HQR

K952151 is an FDA 510(k) premarket notification submitted by Storz for the device "STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)". The FDA issued a decision of Substantially Equivalent on March 4, 1996. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Storz has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1996
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Device Class
Class II
Regulation Number
886.4100
Review Panel
OP
Submission Type

Other clearances by Storz

  • K960007 — STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (March 26, 1996)
  • K954340 — STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE (December 14, 1995)
  • K930278 — STORZ COMPUSCAN AB (February 9, 1994)
  • K926512 — STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE (September 9, 1993)
  • K913504 — STORZ MICRO CUTTER 25 GAUGE PACK (February 21, 1992)

Other clearances for product code HQR

  • K050308 — THERMAL CAUTERY PROBE (February 25, 2005)
  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • K980522 — REFRACTEC MCS-100 (July 22, 1998)
  • K972749 — PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) (March 13, 1998)
  • K955158 — SURGITRON (February 9, 1996)
  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)

FDA data resources