Turbett Surgical Container— 510(k) K153025
Substantially EquivalentTurbett Surgical, LLC
FDA 510(k) clearance K153025 for Turbett Surgical Container, Substantially Equivalent on 2016-01-14. Applicant: Turbett Surgical, LLC. Device class: 2.
Clearance details
- Applicant
- Turbett Surgical, LLC
- Product code
- Code FRG
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code FRG
view allAdverse events under product code FRG
product code FRG- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K153025
K-number listed on FDA's recall record- Z-1037-2023 — Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Z-1038-2023 — Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
- Z-1501-2022 — Turbett Surgical Container, TS1500
- Z-1111-2022 — Turbett Surgical Container, TS1500
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153025.
Data sourced from openFDA. This site is unofficial and independent of the FDA.