NYLON COATED SPECULA
FDA 510(k) clearance K925501 · decided 1997-06-13
Clearance details
- K-number
- K925501
- Device name
- NYLON COATED SPECULA
- Applicant
- Zinnanti Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-30
- Decision date
- 1997-06-13
- Days to decision
- 1687 days
- Clearance type
- Traditional
- Product code
- HIB
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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.