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510(k) K932782

HM-0660 by Hill-Med, Inc. — Product Code HEX

K932782 is an FDA 510(k) premarket notification submitted by Hill-Med, Inc. for the device "HM-0660". The FDA issued a decision of Substantially Equivalent on March 23, 1994. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Hill-Med, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1994
Date Received
June 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

Other clearances by Hill-Med, Inc.

  • K993991 — HM-930 ELECTROSURGICAL UNIT (May 30, 2000)
  • K981781 — ELECTROSURGICAL UNIT (December 4, 1998)
  • K961473 — HM-88011 SOLID STATE ELECTR SURGICAL UNIT (May 7, 1996)
  • K951718 — HM-SPIRO (December 20, 1995)
  • K940140 — HM-CRYO (June 27, 1994)
  • K932896 — HM-0690 COLPOSCOPE (March 23, 1994)
  • K932817 — HM-880 I (March 9, 1994)
  • K932818 — HM-880 (February 25, 1994)
  • K932720 — HM-0970 (September 7, 1993)

Other clearances for product code HEX

  • K233043 — Smart Scope® CX (June 14, 2024)
  • K190187 — Gynescope System (May 8, 2019)
  • K182764 — Biop Digital Colposcope (November 27, 2018)
  • K181034 — Pocket Colposcope System (September 21, 2018)
  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K161871 — EVA (Enhanced Visual Assessment) System (December 19, 2016)
  • K160341 — Colposcope System (September 14, 2016)
  • K160380 — LT-300 HD (May 13, 2016)
  • K151878 — Video Colposcope (December 1, 2015)
  • K143119 — LT-300 Video Colposcope (December 18, 2014)

FDA data resources