FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
K Number: K000628
·
Decision Mar 13, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
- K Number
- K000628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sims Portex , Ltd.
- Date Received
- February 24, 2000
- Decision Date
- March 13, 2000
- Product Code
- MQE
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQE | Needle, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Sims Portex , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K012277 | PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE | Feb 11, 2002 | Substantially Equivalent |
| K012068 | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S | Aug 3, 2001 | Substantially Equivalent |
| K001555 | SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 | Aug 2, 2000 | Substantially Equivalent |