Ancora-SB
FDA 510(k) K231323 · Aspero Medical, Inc.
510(k) numberK231323
Submission
- Device name
- Ancora-SB
- Applicant
- Aspero Medical, Inc.
Fort Collins, CO, US - Received
- May 8, 2023
- Decision date
- August 31, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDA – Enteroscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FDA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260314 | Ancora-SBFDA · Traditional | Aspero Medical, Inc. | 05/01/2026SE |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000)FDA · Traditional | FUJIFILM Healthcare Americas Corporation | 09/26/2025SE |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214CFDA · Traditional | FUJIFILM Healthcare Americas Corporation | 06/13/2024SE |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFDA · Special | Fujifilm Corporaton | 01/11/2023SE |
| K213195 | Balloon BS-3FDA · Special | Fujifilm Corporation | 10/29/2021SE |
| K191330 | Arc EnterocuffFDA · Traditional | Boddingtons Plastics, Ltd. | 01/31/2020SE |
| K183032 | FUJIFILM Double Balloon Endoscope EI580BTFDA · Traditional | Fujifilm Corporation | 06/24/2019SE |
| K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5FDA · Special | Fujifilm Corporation | 02/27/2019SE |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFDA · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 08/20/2015SE |
| K071254 | Small Intestinal Videoscope SystemFDA · Traditional | Olympus Medical Systems Corporation | 03/25/2008SE |
More from Olympus Medical Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K260314 | Ancora-SBFDA · Traditional | 05/01/2026SE |
Questions and answers
When was Ancora-SB cleared by the FDA?
Ancora-SB (K231323) received a 510(k) decision of Substantially Equivalent on August 31, 2023, 115 days after the submission was received.
What is the product code of K231323?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.