Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
The Fixation device for Pelvic Use (Non-Absorbable or Absorbable) is a surgical implant used to attach suture or staple the ligaments of the pelvic floor during reconstructive pelvic surgery, such as procedures to treat pelvic organ prolapse. It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class 2 device under regulation 884.4530, requiring 510(k) premarket notification. As an implanted device, it is subject to general controls and special controls; it is not considered life-sustaining.
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Basic Information
- Product Code
- PBQ
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
Attaching suture or stapling ligaments of the pelvic floor.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260380 | Mendit | Mar 04, 2026 | Substantially Equivalent | Escala Medical, Ltd. |
| K230730 | Apyx | Jul 25, 2023 | Substantially Equivalent | Escala Medical |
| K220420 | Saffron Fixation System | Jun 10, 2022 | Substantially Equivalent | Coloplast A/S |
| K213783 | Apyx | Apr 05, 2022 | Substantially Equivalent | Escala Medical |
| K160569 | NeuGuide | Jul 06, 2016 | Substantially Equivalent | Pop Medical Solutions |
| K130059 | ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP | Jul 29, 2013 | Substantially Equivalent | Ibi Israel Biomedical Innovations , Ltd. |
| K120831 | ANCHORSURE | Oct 12, 2012 | Substantially Equivalent | Neomedic International S.L. |
| K042603 | GYNECARE PROLENE FASTENER SYSTEM | Dec 22, 2004 | Substantially Equivalent | ETHICON, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.