# Grace Medical, Inc.

- Location (FDA's records): Memphis, TN
- FDA decisions: 15 (1994–2026): 15 510(k) clearances
- Product codes: ETB (7), ETD (5), ERL (1), ETA (1), KHJ (1)
- Predicates its devices cite: 30 (9 its own); citations of its devices by later devices: 10 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gyrus Ent LLC: 8 (https://510kreport.com/company/gyrus-ent)
- Heinz Kurz GmbH Medizintechnik: 6 (https://510kreport.com/company/heinz-kurz-medizintechnik)
- Heinz Kurz: 4 (https://510kreport.com/company/heinz-kurz)
- Micromedics, Inc.: 1 (https://510kreport.com/company/micromedics)
- Bien-Air Surgery SA: 1 (https://510kreport.com/company/bien-air-surgery)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)

## Firms that cite its devices most
- Heinz Kurz GmbH Medizintechnik: 1 (https://510kreport.com/company/heinz-kurz-medizintechnik)

## Its most-cited devices
- K943325: Tympanostomy Tube (1994), cited by 2
- K061853: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses (2006), cited by 2
- K991394: Stapes Prostheses (1999), cited by 1
- K981575: Tympanostomy Tube (1998), cited by 1
- K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes (2006), cited by 1
- K080070: K-Helix Piston and Porp Partial Ossicular Replacement Prostheses (2008), cited by 1

## Recent decisions
- K260266: Tympendi™ (810) (Aug 18, 2026)
- K232059: Tympanostomy Tubes (Nov 24, 2023)
- K161376: DragonFly Surgical Drill System (Aug 25, 2016)
- K091187: Grace Dynamic Torp (Sep 14, 2009)
- K080070: K-Helix Piston and Porp Partial Ossicular Replacement Prostheses (Apr 17, 2008)
- K063374: Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe (Dec 6, 2006)
- K062672: Grace Medical PC Coated Tympanostomy Tubes (Oct 24, 2006)
- K062385: Blue Ptfe (Fluoroplastic) Ventilation Tubes (Sep 27, 2006)

Source page: https://510kreport.com/company/grace-medical