Identity
- Trade Name
- APYX Retriever Set FDA UDI
- Generic Name
- Soft-tissue/mesh anchor, bioabsorbable FDA UDI
- Device Name
- The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to. FDA UDI
- Model / Reference
- Apyx Retriever Set Resorbable Suture FDA UDI
- Description
- The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to. FDA UDI
Identifiers
- Catalog Number
- ES0149 FDA UDI
- Primary DI / UDI-DI
- 07290019174011 FDA UDI
- 510(k) Number
- K213783 FDA UDI
- FDA Product Code
- PBQ FDA UDI
- GMDN Term
- Soft-tissue/mesh anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Soft-tissue/mesh anchor, bioabsorbable
APYX Retriever Set by Escala Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue/mesh anchor, bioabsorbable.
- OPTIFIX — Davol Inc. · Class II
- Integrity Implant Fixation Kit — Anika Therapeutics, Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- OPTIFIX — Davol Inc. · Class II
- TissueTak™ — Via Surgical , Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- FasTouch™ Absorbable — Via Surgical , Ltd. · Class II
- SORBAFIX — Davol Inc. · Class II
Cleared under the same submission
K213783 also covers:
- APYX Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Applicator Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Reload Set — Escala Medical
- Mendit Retriever Set — Escala Medical
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Escala Medical
Sources (1)
- FDA UDI 5922b5ff-44b3-4fc7-9922-234465fc6d6c 36 fields · synced Jun 1, 2026