CORE-SPORT
FDA 510(k) clearance K220081 · decided 2022-09-28
Clearance details
- K-number
- K220081
- Device name
- CORE-SPORT
- Applicant
- Incore Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-10
- Decision date
- 2022-09-28
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- OTJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Daegu, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Incore Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Uni-port (K232062) | Dalim Medical Corp. | 2024-01-16 |
| AFS Medical Sterile Single-Use Access Port System (K202688) | Afs Medical Co. , Ltd. | 2021-10-14 |
| FMX314 Surgical Platform (K160797) | Fortimedix Surgical B.V. | 2016-08-26 |
| Endo Keeper (K152598) | Nelis | 2016-03-17 |
| ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE (K121309) | Advanced Surgical Concepts | 2012-09-06 |
| KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA (K120898) | Richard Wolf Medical Instruments Corp. | 2012-08-03 |
| TRIPORT, TRIPORT+, TRIPORT15, QUADPORT (K111407) | Advanced Surgical Concepts | 2012-01-18 |
| OCTOTMPORT (K112196) | Dalim Surgnet Corporation | 2011-09-14 |
| ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE (K110004) | Advanced Surgical Concepts | 2011-01-26 |
| ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA (K101794) | Advanced Surgical Concepts | 2010-11-29 |
Recalls involving this device
No recalls on record reference this clearance.