Company ยท US
Hk Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2020. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2020 | K193664 | SubQKath Catheter and Needle Set Hk Surgical | BSO |
| Sep 27, 2013 | K123822 | KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET Hk Surgical, Inc. | FRN |
| Nov 19, 2003 | K032802 | HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III Hk Surgical, Inc. | QPB |
| Aug 7, 2003 | K031432 | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II Hk Surgical, Inc. | FRN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2005 | HK Surgical Inc Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15. Terminated |
FIE | None listed |
| Jun 17, 2005 | HK Surgical Inc Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8 Terminated |
FIE | None listed |
| Jun 17, 2005 | HK Surgical Inc Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6 Terminated |
FIE | None listed |