WELLINGTON HOSPITAL PATTERN SELF-RETAIN
FDA 510(k) clearance K843388 · decided 1984-10-01
Clearance details
- K-number
- K843388
- Device name
- WELLINGTON HOSPITAL PATTERN SELF-RETAIN
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-29
- Decision date
- 1984-10-01
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- HDF
- Device class
- 1
- Regulation number
- 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT (K926429) | Thomasville Medical Assoc. | 1994-02-28 |
| MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS (K902019) | Gynescope Corp. | 1990-06-07 |
| MIYA SPECULUM (K891041) | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| LASER SPECULA (K891044) | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| VAGINAL SPECULUM (K890375) | Kinetic Medical Products | 1989-02-13 |
| HAYES VAGINAL SHIELD (K862478) | Franklin Medical USA, Inc. | 1986-11-24 |
| WELLINGTON HOSPITAL PATTERN SELF RETAINING VAGINAL (K853640) | Downs Surgical , Ltd. | 1985-10-29 |
| 61-100 TO 61-124 VARIOUS VAGINAL SPECVIA(CUSCO,GRA (K851799) | Artiberia | 1985-05-22 |
| PEDERSON VAGINAL SPECULA (K821291) | Conphar, Inc. | 1982-05-24 |
| GRAVES SPECULA (K821297) | Conphar, Inc. | 1982-05-24 |
Recalls involving this device
No recalls on record reference this clearance.