GYNECOLOGIC EXAMINATION KIT
FDA 510(k) clearance K894489 · decided 1989-10-05
Clearance details
- K-number
- K894489
- Device name
- GYNECOLOGIC EXAMINATION KIT
- Applicant
- A & A Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-10-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- HIB
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Branford, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch A & A Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| JFord Speculum Sleeve™ (K252208) | Ford Medtech, LLC | 2026-03-06 |
| BRELLA-SPEC(TM) VAGINAL SPECULUM (K133857) | Proa Medical, Inc. | 2014-04-28 |
| IOB DISPOSABLE SPECULUM (K132668) | Iob Medical, Inc. | 2014-01-17 |
| CLEARSPEC SINGLE USE VAGINAL SPECULUM (K130046) | Clearspec, LLC | 2013-08-06 |
| SPECULUM, VAGINAL, NONMETAL (K120743) | Welch Allyn, Inc. | 2012-03-23 |
| KOLPLUX SYSTEM (K110766) | Kolplast CI Ltda | 2011-09-15 |
| NON-STERILE DISPOSABLE VAGINAL SPECULUM (K092870) | Kunshan Deyi Plastic Co., Ltd. | 2010-02-16 |
| OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (K091937) | Obp Corporation | 2009-09-09 |
| MEDLINE DISPOSABLE VAGINAL SPECULUM (K072942) | Medline Industries, Inc. | 2008-02-08 |
| DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (K072762) | Depalt, Inc. | 2008-01-22 |
| KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM (K070964) | Welch Allyn, Inc. | 2007-05-18 |
| HIERSPEC SPECULUM (K061339) | Medical Products Div. | 2006-09-19 |
Recalls involving this device
No recalls on record reference this clearance.