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510(k) K955158

SURGITRON by Ellman Intl., Inc. — Product Code HQR

K955158 is an FDA 510(k) premarket notification submitted by Ellman Intl., Inc. for the device "SURGITRON". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Ellman Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1996
Date Received
November 13, 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 Ellman Intl., Inc.

  • K013255 — SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (November 7, 2001)
  • K003126 — BIPOLAR TRIGGER-FLEX PROBE (April 11, 2001)
  • K001986 — SURGITRON IEC II (September 27, 2000)
  • K001407 — SURGITRON IEC II (July 24, 2000)
  • K001253 — SURGITRON IEC II (May 26, 2000)
  • K992382 — SURGITRON RADIOLASE (October 14, 1999)
  • K990146 — SURGITRON (March 17, 1999)
  • K980177 — SUGITRON MODEL: IEC (July 7, 1998)
  • K980170 — SURGITRON (June 29, 1998)
  • K972072 — SURGITRON MODEL FFPF-EMC (June 19, 1997)

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)
  • 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