Panels › Obstetrics/Gynecology › Product code HIB · Class 2
Speculum, Vaginal, Nonmetal
Regulation 884.4530
1510(k)s in 12 months (72 all time)
1recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in HIB
| Company | 510(k)s | Recalls |
|---|---|---|
| CooperSurgical, Inc. | 1 | 4 |
| Welch Allyn, Inc. | 3 | 1 |
| C.I.S.A. Import Export C/O Larson and Taylor | 3 | 0 |
| Sol Weiss MD, Inc. | 3 | 0 |
| Exitec, Inc. | 2 | 0 |
| Femspec LLC | 2 | 0 |
| Martin Medical | 2 | 0 |
| Zinnanti Surgical Instruments, Inc. | 2 | 0 |
| A & A Medical, Inc. | 1 | 0 |
| Adept-Med Intl., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2026 | OBP Medical Corporation OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small
REF: C020130-1 Open, Classified |
HIB | K091937 |
| Jul 18, 2025 | CooperSurgical, Inc. Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV.
Endosee System Convenience Kit with IV Tube. Open, Classified |
HIB | K920803 |
| Jul 18, 2025 | CooperSurgical, Inc. Endosee System Convenience Kit. Model Number: ES-TRAY.
Endosee System Convenience Kit Open, Classified |
HIB | K920803 |
| Jul 18, 2025 | CooperSurgical, Inc. HSG Procedure Tray. Model Number: 6050T.
The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures. Open, Classified |
HIB | K920803 |
| Oct 30, 2015 | Welch Allyn Inc Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78 Terminated |
HIB | K120743 |
| Jun 22, 2015 | CooperSurgical, Inc. McKesson Medi-Pak Vaginal Speculum, 10/bag
Reorder No. 11-8309
Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures Terminated |
HIB | K841909 |
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