AUTOCLAVE POUCHES&ROLLS/STEAM&GAS
FDA 510(k) clearance K780034 · decided 1978-02-21
Clearance details
- K-number
- K780034
- Device name
- AUTOCLAVE POUCHES&ROLLS/STEAM&GAS
- Applicant
- E.M. Adams
- Decision
- Substantially Equivalent
- Date received
- 1978-01-09
- Decision date
- 1978-02-21
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology (K261897) | O&M Halyard, Inc. | 2026-07-02 |
| Dukal Crepe Paper Sterilization Wrap (K252823) | Dukal, LLC | 2026-05-28 |
| HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap (K253454) | O&M Halyard, Inc. | 2026-05-18 |
| Sterilization Pouch/Roll (K251347) | Sterivic Medical Co., Ltd. | 2026-01-28 |
| Self-Seal Sterilization Pouch and Roll (K251177) | Guangdong Maidi Medical Co., Ltd. | 2025-12-12 |
| Chex-All Sterilization Pouches and Tubes (K250306) | Propper Manufacturing Co., Inc. | 2025-10-31 |
| Sterilization Pouch and Roll (K243179) | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 |
| GCI Sterilization Wrappers (K250321) | George Courey, Inc. | 2025-06-06 |
| Self Sealing Sterilization Pouches (K243721) | Wellmed Dental Medical Supply Co., Ltd. | 2025-04-25 |
| Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000) (K250011) | Turbett Surgical | 2025-04-04 |
| Sterilization Package/Reel (K241565) | Anqing Clean Dental Instrument Technology Co., Ltd. | 2025-02-24 |
| Medicom Sterilization Pouch and Reel (K243431) | Medicom Asia-Pacific Holdings Ltd. Taiwan Branch. | 2025-02-21 |
Recalls involving this device
No recalls on record reference this clearance.