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510(k) K952569

GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR by Gamp & Assoc. — Product Code HQR

K952569 is an FDA 510(k) premarket notification submitted by Gamp & Assoc. for the device "GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR". The FDA issued a decision of Substantially Equivalent on January 5, 1996. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Gamp & Assoc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1996
Date Received
June 5, 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 Gamp & Assoc.

  • K952581 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR (January 5, 1996)
  • K952585 — GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR (January 5, 1996)
  • K954306 — GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE (December 22, 1995)
  • K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE (December 22, 1995)
  • K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE (December 22, 1995)
  • K952584 — GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK (September 1, 1995)
  • K952580 — GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (September 1, 1995)
  • K952586 — GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (September 1, 1995)

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)
  • K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR C (March 4, 1996)
  • K955158 — SURGITRON (February 9, 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