Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)2Product Code
- HETLaparoscope, Gynecologic (And Accessories)2Product Code
- HEWCuldoscope (And Accessories)2Product Code
- HEXColposcope (And Colpomicroscope)2Product Code
- HEZEndoscope, Transcervical (Amnioscope)(And Accessories)2Product Code
- HFAAmnioscope, Transabdominal (Fetoscope) (And Accessories)FProduct Code
- HFCAspirator, Endocervical2Product Code
- HFDWasher, Endometrial2Product Code
- HFEBrush, Endometrial2Product Code
- HFFAspirator, Endometrial2Product Code
- HGKEndoscope, Fetal Blood Sampling (And Accessories)2Product Code
- HGWSampler, Blood, Fetal2Product Code
- HHKCurette, Suction, Endometrial (And Accessories)2Product Code
- HIFInsufflator, Laparoscopic2Product Code
- HIGInsufflator, Hysteroscopic2Product Code
- HIHHysteroscope (And Accessories)2Product Code
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)1Product Code
- LHZViscometer, Mucus, Cervical1Product Code
- MKOFalloposcope2Product Code
- MOKVaginoscope And Accessories2Product Code
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic1Product Code
- NMHLaparoscope And Accessories, Gynecologic, Reprocessed2Product Code
- NMILaparoscopic Insufflator And Accessories, Reprocessed1Product Code
- NVTTubing And Tubing/Filter Fits1Product Code
- NWVLaparoscopic Accessories, Gynecologic1Product Code
- NWWHysteroscope Accessories1Product Code
- PCFSampler, Endocervical2Product Code
- OHDGynecological Laparoscopic Kit2Product Code
- OHEForensic Evidence Sexual Assault Kit2Product Code
- OHFCuldocentesis Kit2Product Code
- OHMCesarean Section Tray2Product Code
- OKXTrocar Kit2Product Code
- PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar2Product Code
- OKZEndometrial Sampling Kit2Product Code
- OSVInsufflator, Endoscopic Vessel Harvesting2Product Code
- PTZColposcope (And Colpomicroscope), Exempt2Product Code
- PVSFetal Blood Sampling Kit (Excludes Hiv Testing)2Product Code
- QHZSeal, Cervical, Mechanical, Unpowered1Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Forensic Evidence Sexual Assault Kit
- Page Type
- Product Code
- Definition
- This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Physical State
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Technical Method
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Target Area
- This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Regulation Medical Specialty
- Obstetrical and Gynecological
- Review Panel
- Obstetrical and Gynecological
- Submission Type
- Enforcement Discretion
- Device Classification
- Class 2
- Regulation Number
- 884.1630
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 884.1630 Colposcope
§ 884.1630 Colposcope.
(a) Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.
(b) Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]