Gynecare Interceed Absorbable Adhesion Barrier
by Ethicon Inc.
PMA P880047
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP880047 | Date15 Sep 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- Interceed TC7 Absorbable Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- FDA applicant
- ETHICON, Inc.
- PMA number
- FDA product code
- MCN
- Device class
- Class III
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
Gynecare Interceed Absorbable Adhesion Barrier is an absorbable adhesion barrier device classified under the generic name 'Barrier, absorbable, adhesion'. It is manufactured by Ethicon Inc. and identified by the trade name INTERCEED TC7 ABSORBABLE ADHESION BARRIER.
The device received FDA PMA approval (P880047) on September 15, 1989, following submission on June 27, 1988. It is designated for use in obstetrics and gynecology as indicated by its OB advisory committee classification and is supplied as a sterile, single-use barrier intended to reduce post-surgical adhesions.
Other devices from Ethicon Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the regulatory status of the Gynecare Interceed Absorbable Adhesion Barrier?
The Gynecare Interceed Absorbable Adhesion Barrier has received FDA Premarket Approval (PMA) under number P880047, which was granted on September 15, 1989, after the application was received on June 27, 1988. This Class III device is authorized for marketing in the United States based on this PMA.
What medical specialty is the Gynecare Interceed Absorbable Adhesion Barrier intended for?
The device is classified under the Obstetrics/Gynecology advisory committee (OB), indicating its intended use in obstetrics and gynecological procedures. This classification reflects the medical specialty context in which the device is evaluated and used.
Is the Gynecare Interceed Absorbable Adhesion Barrier a reusable or single-use device?
While the provided data does not explicitly state whether the device is reusable or single-use, it is identified as an absorbable adhesion barrier with a trade name of INTERCEED TC7 ABSORBABLE ADHESION BARRIER. Absorbable barriers like this are typically designed for single-use implantation during surgery and are not intended for reprocessing or reuse.