Modification to En-Bloc Biopsy System
FDA 510(k) K052246 · Neothermia Corporation
510(k) numberK052246
Submission
- Device name
- Modification to En-Bloc Biopsy System
- Applicant
- Neothermia Corporation
Natick, MA, US - Received
- August 17, 2005
- Decision date
- August 22, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K050737 | Neothermia En-Bloc Biopsy SystemGEI · Special | 03/31/2005SE |
| K042170 | En-Bloc Biopsy System MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-1…GEI · Special | 09/07/2004SE |
| K041347 | Modification to En-Bloc Biopsy SystemGEI · Special | 06/04/2004SE |
| K033427 | Modification to En-Bloc Biopsy SystemKNW · Special | 11/10/2003SE |
| K023413 | Modification to Neothermia's En-Bloc Biopsy SystemGEI · Special | 11/08/2002SE |
| K022296 | Modification to En-Bloc Biopsy SystemGEI · Special | 07/30/2002SE |
| K021577 | Modification to En-Bloc Biopsy SystemGEI · Special | 05/29/2002SE |
| K020031 | En-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302GEI · Traditional | 03/27/2002SE |
| K003190 | En Bloc Biopsy SystemGEI · Traditional | 06/11/2001SE |
Questions and answers
When was Modification to En-Bloc Biopsy System cleared by the FDA?
Modification to En-Bloc Biopsy System (K052246) received a 510(k) decision of Substantially Equivalent on August 22, 2005, 5 days after the submission was received.
What is the product code of K052246?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.