# Medispec, Ltd.

- Location (FDA's records): Germantown, MD
- FDA decisions: 6 (1997–2023): 4 510(k) clearances and 2 original PMA approvals
- Product codes: LNS (3), ISA (1), FFK (1), NBN (1)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Electro Medical Systems SA: 2 (https://510kreport.com/company/electro-medical-systems)
- Tissue Regeneration Technologies, LLC: 1 (https://510kreport.com/company/tissue-regeneration-technologies)
- Storz Medical AG: 1 (https://510kreport.com/company/storz-medical)
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)
- Healthtronics Surgical Services, Inc.: 1 (https://510kreport.com/company/healthtronics-surgical-services)

## Firms that cite its devices most
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Lite-Med, Inc.: 1 (https://510kreport.com/company/lite-med)

## Its most-cited devices
- K063504: Econolith EM1000 (2007), cited by 2
- K040461: Econolith E3000, Model 3000 (SW-6) (2004), cited by 1

## Recent decisions
- K210166: Omnispec ED1000 (Jan 27, 2023)
- K063504: Econolith EM1000 (Mar 9, 2007)
- P040026: Orthospec Extracorporeal Shock Wave Therapy Device (Apr 1, 2005)
- K040461: Econolith E3000, Model 3000 (SW-6) (May 25, 2004)
- K974796: Lithospec (TM) Intracorporeal Lithotripter (Mar 12, 1998)
- P950043: Econolith (TM) Lithotripter (Apr 7, 1997)

Source page: https://510kreport.com/company/medispec