The following data is part of a premarket notification filed by Hangzhou Shuyou Medical Instrument Company, Ltd. with the FDA for Electrosurgical Pencils.
| Device ID | K040780 |
| 510k Number | K040780 |
| Device Name: | ELECTROSURGICAL PENCILS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | HANGZHOU SHUYOU MEDICAL INSTRUMENT COMPANY, LTD. 6868 COLONY DRIVE West Bloomfield, MI 48323 |
| Contact | Jian Chen, M.d. |
| Correspondent | Jian Chen, M.d. HANGZHOU SHUYOU MEDICAL INSTRUMENT COMPANY, LTD. 6868 COLONY DRIVE West Bloomfield, MI 48323 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-26 |
| Decision Date | 2005-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16924274958083 | K040780 | 000 |
| 6924274910701 | K040780 | 000 |
| 6924274910756 | K040780 | 000 |
| 6924274910800 | K040780 | 000 |
| 6924274910855 | K040780 | 000 |
| 6924274910909 | K040780 | 000 |
| 06924274910114 | K040780 | 000 |
| 6924274911005 | K040780 | 000 |
| 6924274911050 | K040780 | 000 |
| 6924274911104 | K040780 | 000 |
| 6924274911159 | K040780 | 000 |
| 6924274911203 | K040780 | 000 |
| 06924274910053 | K040780 | 000 |
| 06924274910046 | K040780 | 000 |
| 16924274957833 | K040780 | 000 |
| 16924274957840 | K040780 | 000 |
| 16924274957857 | K040780 | 000 |
| 16924274957635 | K040780 | 000 |
| 16924274957161 | K040780 | 000 |
| GYNX755VL1 | K040780 | 000 |
| GYNX9501 | K040780 | 000 |
| 6924274910404 | K040780 | 000 |
| 6924274910459 | K040780 | 000 |
| 6924274910503 | K040780 | 000 |
| 6924274910558 | K040780 | 000 |
| 06924274910176 | K040780 | 000 |
| 6924274911302 | K040780 | 000 |
| 6924274911357 | K040780 | 000 |
| 6924274912057 | K040780 | 000 |
| 6924274912101 | K040780 | 000 |
| 6924274912156 | K040780 | 000 |
| 6924274912200 | K040780 | 000 |
| 6924274912255 | K040780 | 000 |
| 06924274910381 | K040780 | 000 |
| 06924274953685 | K040780 | 000 |
| 06924274955542 | K040780 | 000 |
| 06924274955917 | K040780 | 000 |
| 06924274955979 | K040780 | 000 |
| 06924274956020 | K040780 | 000 |
| 6924274912002 | K040780 | 000 |
| 6924274911951 | K040780 | 000 |
| 6924274911401 | K040780 | 000 |
| 6924274911456 | K040780 | 000 |
| 6924274911500 | K040780 | 000 |
| 6924274911555 | K040780 | 000 |
| 6924274911609 | K040780 | 000 |
| 6924274911654 | K040780 | 000 |
| 6924274911708 | K040780 | 000 |
| 6924274911753 | K040780 | 000 |
| 6924274911807 | K040780 | 000 |
| 6924274911852 | K040780 | 000 |
| 6924274911906 | K040780 | 000 |
| 06924274956075 | K040780 | 000 |