HIGClass II
Insufflator, Hysteroscopic
21 CFR 884.1700 / Obstetrics/Gynecology
HIG is the FDA product code for Insufflator, Hysteroscopic, a class II device type, regulated under 21 CFR 884.1700. As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- HIG
- Device name
- Insufflator, Hysteroscopic
- Regulation
- 21 CFR 884.1700
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 57
- Ingested recalls
- 6
Clearances, product code HIG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 5 |
| 1993 | 1 |
| 1994 | 6 |
| 1995 | 6 |
| 1996 | 1 |
| 1997 | 3 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 4 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| 2026 | 2 |
Applicants with the most clearances
Product code HIG| Applicant | Clearances |
|---|---|
| Novanta Medical GmbH | 10 |
| Davol Inc., Sub. C.R. Bard, Inc. | 5 |
| Karl Storz Endoscopy-America, Inc. | 5 |
| Thermedx LLC | 4 |
| Cabot Medical Corp. | 3 |
| Karl Storz SE & Co. KG | 3 |
| F.M. Wiest USA, Inc. | 2 |
| Hologic, Inc. | 2 |
| Ackrad Laboratories | 1 |
| Axcan Scientific Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.