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510(k) K895800

ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR by Advanced Surgical Products, Inc. — Product Code HQR

K895800 is an FDA 510(k) premarket notification submitted by Advanced Surgical Products, Inc. for the device "ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Advanced Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
September 28, 1989
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 Advanced Surgical Products, Inc.

  • K030926 — FAST THROW STAINLESS STEEL SURGICAL SUTURE (July 21, 2003)
  • K896754 — I/A HANDPIECE (January 11, 1990)
  • K896305 — MULTI-USE I/A HANDPIECE (December 18, 1989)
  • K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE (May 12, 1989)
  • K884556 — DREYER CURVED ENDOILLUMINATOR (February 28, 1989)
  • K890398 — RYAN-STYLE DIRECTED INFUSION MANIPULATOR (February 17, 1989)
  • K884347 — MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN (December 27, 1988)
  • K883857 — FIBEROPTIC WIRE PICK LIGHTPIPE (September 29, 1988)
  • K883856 — FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE (September 29, 1988)
  • K883858 — FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE (September 29, 1988)

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)
  • 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)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)

FDA data resources