Gastrotec
by Patrick C. Jacobssen 510(k)
Active
510(k) K954401
Overview
The Gastrotec is a polymer-based, natural-absorbable gelatin material device classified under product code ESI (Endoscopic Surgical Instruments). It is designed for use in endoscopic procedures within the ear, nose, and throat (ENT) specialty, serving as a temporary or absorbable support material during surgical interventions.
Supplied as a single-use device, the Gastrotec is intended for sterile application in controlled clinical settings. Its absorbable gelatin composition ensures biocompatibility and gradual resorption post-procedure, eliminating the need for removal. Regulated under FDA 510(k) clearance (K954401), it was granted Substantially Equivalent (SESE) status in 1996 via the Traditional 510(k) pathway. No additional regulatory markings or MRI safety classifications are specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954401 | Date25 Apr 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ESI
- Device Class
- Class III
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Gastrotec used for during ENT procedures and why is its absorbable material an advantage?
The Gastrotec is designed as a temporary, polymer-based gelatin support material used during endoscopic ENT surgeries. Its absorbable nature ensures it gradually dissolves after use, eliminating the need for a second procedure to remove it. This reduces patient discomfort, lowers infection risk, and simplifies post-operative care compared to permanent implants.
Is the Gastrotec meant for reuse or is it single-use only, and how should it be handled before use?
The Gastrotec is explicitly supplied as a single-use device, intended for sterile application in controlled clinical settings. Since it’s absorbable and polymer-based, it should be stored in its original packaging until use, ensuring sterility and preventing contamination before the procedure.
How was the Gastrotec’s regulatory pathway determined, and what does the SESE status mean for its use?
The Gastrotec was granted Substantially Equivalent (SESE) status under the Traditional 510(k) pathway in 1996, meaning the FDA determined it was as safe and effective as a legally marketed predicate device. This classification confirms its compliance with FDA standards for endoscopic surgical instruments (product code ESI) and allows its use in approved ENT procedures without additional restrictions.
Are there different sizes or models of the Gastrotec, and if so, how would a clinician determine the right fit for a patient?
The provided specifications do not list specific sizes or models for the Gastrotec, so its design appears standardized for general ENT endoscopic procedures. Clinicians should refer to the manufacturer’s instructions or consult with the supplier to confirm compatibility with the surgical site and patient anatomy, as absorbable support materials may vary in application flexibility.