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OPUS Silicone Gel Breast Implant Sizer
FDA UDIFDA 510(k)Class U (US FDA UDI)
510(k) K200706
Identity
- Trade Name
- OPUS Silicone Gel Breast Implant Sizer FDA UDI
- Generic Name
- Invasive breast implant sizer, fixed, single-use FDA UDI
- Device Name
- Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 535 cc FDA UDI
- Model / Reference
- GS10621-535HP FDA UDI
- Description
- Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 535 cc FDA UDI
Identifiers
- Catalog Number
- GS10621-535HP FDA UDI
- Primary DI / UDI-DI
- 00819409023684 FDA UDI
- 510(k) Number
- K200706 FDA UDI
- FDA Product Code
- MRD FDA UDI
- GMDN Term
- Invasive breast implant sizer, fixed, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Invasive breast implant sizer, fixed, single-use
OPUS Silicone Gel Breast Implant Sizer by Sientra, Inc. — Class U — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Invasive breast implant sizer, fixed, single-use.
- MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High Profile — Mentor Texas LP · U
- Single Use Sterile Saline Breast Implant Sizer for Natrelle Style 68 LP — SPECIALTY SURGICAL PRODUCTS, INC. · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
- Round Breast Implant Sizer, High Projection — SPECIALTY SURGICAL PRODUCTS, INC. · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
- Round Breast Implant Sizer, Moderate Plus Projection — SPECIALTY SURGICAL PRODUCTS, INC. · U
- NATRELLE INSPIRA Single Use Sizers — Allergan · U
Cleared under the same submission
K200706 also covers:
- OPUS Silicone Gel Breast Implant Sizer — Sientra, Inc.
- OPUS Silicone Gel Breast Implant Sizer — Sientra, Inc.
- OPUS Silicone Gel Breast Implant Sizer — Sientra, Inc.
- OPUS Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
- SIENTRA Silicone Gel Breast Implant Sizer — Sientra, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200706 | Class U | Active |
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Manufacturer
- Manufacturer
- Sientra, Inc.
Sources (2)
- FDA UDI 078daf5f-7289-4b6b-b101-d92910b617db 61 fields · synced Jun 18, 2026
- FDA 510(k) K200706 1 fields · synced May 25, 2026