FDA product code PLL: Submucosal Injection Agent
PLL is the FDA product code for submucosal injection agent. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 10 510(k) submissions under PLL, 4 in the last five years, from 8 different applicants. The average 510(k) review took 182 days (median 172); 98 days on average over the last three years. FDA has posted 1 recall for PLL devices, 1 initiated in the last five years.
Definition
Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
Classification
| Field | Value |
|---|---|
| Device name | Submucosal Injection Agent |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PLL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 262 |
| 2020 | 4 | 235 |
| 2022 | 2 | 134 |
| 2024 | 1 | 30 |
| 2026 | 1 | 167 |
Compare with all 510(k) review times · Search every PLL clearance
Top PLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Endoclot Plus Co., Ltd. | 2 | 2026-09-09 |
| The Standard Co., Ltd. | 2 | 2024-07-03 |
| Ovesco Endoscopy AG | 1 | 2022-08-11 |
| Micro-Tech (Nanjing) Co., Ltd. | 1 | 2020-11-03 |
| Gi Supply, Inc. | 1 | 2020-09-30 |
3 more applicants have PLL clearances. See the full list in Caduvo.
Most recent PLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260997 | Endoclot Plus Co., Ltd. | SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) | 2026-09-09 | 167 |
| K241591 | The Standard Co., Ltd. | Blue Eye | 2024-07-03 | 30 |
| K220434 | The Standard Co., Ltd. | Blue Eye (TS-905) | 2022-08-12 | 178 |
| K221385 | Ovesco Endoscopy AG | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | 2022-08-11 | 90 |
| K200071 | Micro-Tech (Nanjing) Co., Ltd. | Blue Beacon Submucosal Injectable Solution | 2020-11-03 | 295 |
Recalls for PLL devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-10-10.
| Year | Recalls |
|---|---|
| 2022 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q9953 — Injection, iron-based magnetic resonance contrast agent, per ml
Frequently asked questions
What is FDA product code PLL?
PLL is the FDA product code for submucosal injection agent. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is PLL?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLL?
Across 10 cleared submissions the average was 182 days from receipt to decision (median 172).
Which companies have the most PLL clearances?
Endoclot Plus Co., Ltd. (2); The Standard Co., Ltd. (2); Ovesco Endoscopy AG (1); Micro-Tech (Nanjing) Co., Ltd. (1); Gi Supply, Inc. (1).
Have PLL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-10-10.
Next steps
- Run an FDA pathway report with predicate devices for product code PLL
- Run a recall and safety report across every PLL manufacturer
- Watch product code PLL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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