The following data is part of a premarket notification filed by Bolder Surgical, Llc with the FDA for Coolseal Generator/csl-200-50, Coolseal Trinity (30 Cm Shaft)/csl-tr105-30, Coolseal Trinity (37 Cm Shaft)/csl-tr105-37, Coolseal Trinity (44 Cm Shaft)/csl-tr105-44, Coolseal Mini (20cm Shaft)/csl-mn103-20.
| Device ID | K202114 |
| 510k Number | K202114 |
| Device Name: | CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 Cm Shaft)/CSL-TR105-30, CoolSeal Trinity (37 Cm Shaft)/CSL-TR105-37, CoolSeal Trinity (44 Cm Shaft)/CSL-TR105-44, CoolSeal Mini (20cm Shaft)/CSL-MN103-20 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bolder Surgical, LLC 331 S. 104th Street, Suite 200 Louisville, CO 80027 |
| Contact | Nicholas Wong |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-07-30 |
| Decision Date | 2020-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850346007099 | K202114 | 000 |
| 10850346007068 | K202114 | 000 |
| 10850346007044 | K202114 | 000 |
| 10850346007037 | K202114 | 000 |
| 00850346007023 | K202114 | 000 |
| 00850346007085 | K202114 | 000 |