Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device colposcope (and colpomicroscope)
Regulation Description Colposcope.
Product CodeHEX
Regulation Number 884.1630
Device Class 2


Premarket Reviews
ManufacturerDecision
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELMED
  SUBSTANTIALLY EQUIVALENT 1
FORTH PHOTONICS HELLAS SA
  SUBSTANTIALLY EQUIVALENT 1
GYNEX CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDGYN
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
SOMETECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SOUNMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
STI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
UNITED PRODUCTS & INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 4
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 2

-
-