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510(k) K980522

REFRACTEC MCS-100 by Refractec, Inc. — Product Code HQR

K980522 is an FDA 510(k) premarket notification submitted by Refractec, Inc. for the device "REFRACTEC MCS-100". The FDA issued a decision of SESU on July 22, 1998. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Refractec, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESU ()
Decision Date
July 22, 1998
Date Received
February 10, 1998
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 Refractec, Inc.

  • K053475 — OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 (March 3, 2006)

Other clearances for product code HQR

  • K050308 — THERMAL CAUTERY PROBE (February 25, 2005)
  • K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (April 4, 1999)
  • 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)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)

FDA data resources